CVRX - CVRx crashes 34% as trial for heart failure therapy fails

Medical device maker CVRx ( NASDAQ: CVRX ) lost ~34% pre-market Tuesday after announcing that its BeAT-HF post-market phase trial for FDA-authorized heart failure therapy Barostim did not reach the primary endpoint with statistical significance.

Barostim is an implantable device that uses neuromodulation to improve the symptoms of heart failure.

According to topline data from BeAT-HF, the study involving 323 patients suffering from heart failure with reduced ejection fraction did not achieve the primary endpoint of a measure combining cardiovascular mortality and heart failure morbidity.

However, a prespecified analysis indicated multiple clinically meaningful data supporting Barostim use, including a measure for all-cause survival without a left ventricular assist device (LVAD) and heart transplant.

“We plan to submit the totality of evidence of BeAT-HF to FDA seeking an expansion of Barostim labeling,” Chief Executive of CVRx ( CVRX ) Nadim Yared said.

Read” Seeking Alpha contributor Zach Bristow upgraded CVRx ( CVRX ) to Buy following a technical analysis.

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